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  1. CDRH FOIA: How to Get Records from CDRH

CDRH Petitions

A petition is a way for individuals, regulated industry or consumer groups to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Additional information about petitions can be found on the page: Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions

Note: All documents are in PDF format.

CDRH Petitions

Docket # Petitioner Subject Date
Filed		 Date of
Interim
Response(s)		 Completion
of Petition
FDA-2023-P-0233 Mark Baker, Soft Lights Foundation FDA issue 21 CFR Part 1040.41 to regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use Light Emitting Diodes 2023/01/22    
FDA-2023-P-0219 David Miller FDA issue a corrective recall requiring corrections to all BlueStar Hemodialysis Machines 2023/01/20    
FDA-2013-P-0615 California State Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board Application for Exemption from Preemption of Device Requirements 2012/06/04    
FDA-2022-P-1151 Mark Baker, President Request FDA to regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use Light Emitting Diodes and that these regulations set restrictions on spatial non-uniformity, chip-level peak luminance and peak radiance, spectral power distribution, and square wave flicker and that the regulations be designed to protect the physical and psychological health, safety, comfort, and civil rights of those who are negatively impacted by LED light 2022/06/13 2022/11/06  
FDA-2022-P-2724 Hooman Noorchashm MD, PhD Revoke the medical device classification of P4HB based products from Becton Dickinson and reclassify these to a "Biologicals" 2022/11/01    
FDA-2022-P-1632 Randall Steinmeyer Requests that the FDA remove the Association for the Advancement of Blood & Biotherapies regulatory authority over DNA testing and transfer said authority to the American Society of Crime Laboratory Directors and halt the sale of the so-called motherless paternity tests. 2022/07/21    
FDA-2021-P-1148 Marlene Keeling Requesting breast implant manufacturers and plastic surgeons who implant or explant breast implants to pay for heavy metal testing and oxidation states of platinum when a woman who has been implanted has been diagnosed with an autoimmune disorder, connective tissue disease, cancer including Breast Implant Associated Large Cell Lymphoma or has the symptoms of Breast Implant Illness and if a breast implanted woman is breastfeeding, breast milk must be tested for heavy metals and oxidation states of platinum 2021/10/21   2022/03/15
FDA-2021-P-0582 James McKim, Ph.D., IONTOX, LLC Requests that FDA reconsider the final decision to decline to review EUA210385 in the public interest and in the interest of justice was received and processed under CFR 10.30  2021/06/03   2021/08/28
FDA-2021-P-0445 Janice S. Lintz Requesting the FDA to standardize the naming of hearing aid features and develop a rating system using international ANSI standards for the various hearing aid features 2021/05/03   2022/09/05
FDA-2021-P-0424 Sam DeMarco Requesting that the FDA amend regulation 21 CFR §890.5150(b), Powered Patient Transport (all other power patient transport), to exempt the classification from premarket notification 2021/04/30   2021/10/19
FDA-2020-P-2289 Consumers for - Loeb & Loeb, LLP and James N. Czaban Requests the FDA to refrain from issuing any Warning Letter, Untitled Letter, or "It Has Come to Our attention" (IHCTOA) letter, or from initiating any other form of enforcement action against manufacturer or marketer of Daily Wear Uniform (scrubs) 2020/12/10 2021/05/20 2022/12/05
FDA-2020-P-2060 Penn Avenue Law & Policy Requesting the FDA to take Additional Administrative Action with respect to the Agency's Policy on Screening and Surveillance Tests During the COVID‐19 Public Health Emergency. 2020/10/07 2021/10/05  
FDA-1994-P-0023 MiniMed Technologies Implantable infusion pump for insulin 1994/07/15 2003/03/21 2004/12/02
FDA-2001-P-0128 Bio-Rad Laboratories Permit mfrs. to allow the use of symbols in IVD labeling 2001/07/10 2002/01/10
2002/09/11		 2003/11/18
FDA-2001-P-0158 Association of Disposable Device Manufacturers Regulate reprocessed single use as reusable medical devices 2001/08/15 2002/02/11 2004/12/29
FDA-2001-A-0410 PA Department of Health Collection kits marketed by the Osborn Group, Inc. 2001/08/24 2002/04/04  
FDA-2001-P-0389 Kyper & Associates LLC To revoke compliance program 7383.003 for class III 510(k) pre-amendment devices 2001/09/05   2003/03/13
FDA-2002-P-0255 St. Jude Medical Electronic labeling programmer/computer that implanted pulse generator 2002/02/26 2002/09/11 2003/09/29
FDA-2002-P-0172 Nocona General Hospital To amend the MQSA standard and FOI act to allow facilities to respond and post responses to warning letters on the Internet. 2002/06/12 2003/03/27 2003/10/21
FDA-2002-P-0079 Russell J. Thomsen, M.D. Over-the-counter sales for hand-held Doppler Fetoscopes 2002/07/29 2003/01/24 2003/06/19
FDA-2002-P-0437 Richard Strolworthy To amend the FDA 510(k) policy to include disclosure & labeling requirements 2002/10/08   2003/04/16
FDA-2002-P-0132 Zuckerman, Spaeder LLP To post responses to warning letters on the Internet 2002/10/30 2003/03/27 2003/10/21
FDA-2003-P-0105 Mettler Electronics Corp. FDA to revoke the medical device tracking order for invusion pumps 2003/03/14   2003/05/28
FDA-2003-P-0166 Associated Pharmacologists & Toxicologists Revoke approval for marketing of menstrual cups 2003/04/18   2003/11/18
FDA-2003-P-0014 Tim Milburn, O.D. Contact Lens 2003/06/24   2004/06/28
FDA-2003-P-0403 Peter M. Rothenberg, MD, MA Exemption for an accessory to an electrode cable 2003/06/30   2003/08/14
FDA-2003-P-0275 Etymotic Research, Inc. Over-the-counter Hearing Aids 2003/08/11   2004/02/13
FDA-2003-P-0342 GudHear, Inc. Professional and Patient Labeling for Hearing Aid Devices 2003/08/11   2004/02/13
FDA-2003-P-0184 Russel J. Thomsen, M.D. Requesting FDA to reconsider decision on Over-the-counter sales for hand-held doppler fetoscopes 2003/09/08 2004/03/08 2004/06/14
FDA-2003-P-0266 Endotec, Inc. Revoke the AIP on Endotec 2003/10/10 2004/03/26  
FDA-2003-P-0411 National Organization for Women. Silicone gel-filled breast implants 2003/11/03   2003/12/03
FDA-2003-P-0124 Chemically Associated Neurological Disorders

Silicone gel-filled breast implants.

 2003/11/18   2003/12/04
FDA-2003-P-0278 Committee for Truth in Psychiatry Maintain ECT in Class III 2003/12/10   2004/09/03
FDA-2004-P-0164 Billy Pierson Med Watch complaint 2003/12/22   2004/04/06
FDA-2004-P-0407 Etymotic Research Inc. TV-TIP Sound Amplifier (WORD) 2004/01/22   2004/07/20
FDA-2004-P-0103 BioRad Issue a written opinion stating that unified, truthful labeling for domestic and international sales is lawful 2004/02/06 2004/07/08 2007/05/02
FDA-2004-P-0407 Gastroparesis and Dysmotilities Association Transfer Enterra Therapy from HUD to PMA 2004/02/26   2004/11/04
FDA-2004-P-0417 Philips Medical Systems Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators 2004/04/06   2004/10/29
FDA-2004-P-0349 Computerized Thermal Imaging Inc. Requesting FDA to permit CTI to supplement the administrative record in connection with CTI's PMA approval 2004/07/01 2004/09/15 2004/10/26
FDA-2004-P-0223 Russel J. Thomsen, M.D. Requesting FDA to hold a public hearings to consider the appropriate regulatory status for low output, hand-held dopppler fetoscopes. 2004/07/26   2005/02/25
FDA-2004-P-0028 Hyman, Phelps & McNamara, PC Requesting FDA to require manufacturers of reprocessed single-use electrosurgical cutting and coagulation devices and accessories to submit validation data. 2004/07/28   2005/11/03
FDA-2004-P-0100 City of Arlington Texas Advisory opinion regarding automatic eternal defibrillators 2004/08/09   2005/03/15
FDA-2004-P-0203 Northwest Community Hospital FDA to take action toward medical device manufacturers regarding the interchangeability of medical devices with one another 2004/08/18    
FDA-2004-P-0285 Endotec, Inc Request to reclass from III to II the Non-Constrained Mobile Bearing Ankle Prostheses. 2005/10/13 2006/04/11  
FDA-2005-A-0248 Bill Pierson Requesting the FDA for an opinion regarding hip joint metal constraint 2005/02/07   2005/08/02
FDA-2005-P-0052 RS Medical Requesting that FDA reclassify non-invasive bone growth stimulator from Class III to Class II 2005/02/09 2005/08/01 2007/04/02
FDA-2005-P-0382 World Wide Medical Technologies FDA safeguard kits for treatment of prostate cancer that use bone wax 2005/02/23 2005/08/16 2009/05/22
FDA-2005-A-0419 Jaeckle Fleischmann & Mugel LLP Concerns on 510(k) for a Medical Device 2005/04/05   2005/11/08
FDA-2005-P-0261 International Myopia Prevention Association Misbranding of prescription distance glasses and contact lenses 2005/05/02 2005/10/28 2006/08/02
FDA-2005-P-0067 Zuckerman Spaeder LLP Requesting disapproval of the silicone-gel filled breast implant products. 2005/05/23 2005/12/05 2006/11/17
FDA-2005-P-0251 Life Measurement Operations Requesting a change of classification of Sonamet Body Composition Analyzer 2005/05/23 2005/10/21 2007/07/02
FDA-2005-P-0070 Scientific Laboratory Products LTD

Request to Change the classification of EEG electrodes from Class II to Class I

Supplemental information submitted by Petitioner

 2005/05/31

2005/11/09

 2007/07/02
FDA-2005-P-0205 Medtronic Xomed Request to reclassify Class III to II for the Lamicel Osmotic Cervical Dilator 2005/07/26    
FDA-2005-P-0136 Public Citizen's Health Research Group FDA to establish tighter regulations governing the process by which Medical Devices are reviewed and recalled 2005/11/10 2006/05/25 2011/07/11
FDA-2005-P-0063 S. Maher Reclassification metal/metal hip prostheses from Class III to Class II 2005/09/19 2006/03/15  
FDA-2005-P-0262 CooperSurgical, Inc. Requesting to reclassify the MCCue CUBA Clinical Ultrasonic Bone Sonometry System 2005/10/26   2006/04/05
FDA-2005-P-0324 Wright Medical Technology Inc. To deny approval of Smith & Nephew premarket approval application for the Birmingham Hip Resurfacing System. 2005/11/01 2005/10/31 2006/05/12
FDA-2005-P-0197 C. Brown, Consumers for Dental Choice Initiate Transfer of Responsibility to Regulate/Classify Dental Amalgam 2005/11/15   2006/10/26
FDA-2005-P-0375 C. Brown, Consumers for Dental Choice Withdraw Draft Regulation on Mercury Amalgam 2005/11/16 2006/10/26  
FDA-2005-P-0008 Planmed Oy Reclassification of Full Field Digital Mammography from class III to class II 2005/12/21 2006/04/18  
FDA-2006-P-0337 Alcohol Monitoring System Petition for the SCRAM Bracelet 2006/01/25    
FDA-2006-P-0140 Regulatory & Clinical Research Institute Reclassification of Tissue Adhesive for Soft Tissue 2006/02/09 2006/08/23 2008/05/05
FDA-2006-P-0024 Chemically Associated Neurological Disorders Stay the approvable of any PMA's for silicone gel-filled breast implants 2006/04/10   2006/11/17
FDA-2006-P-0460 Banner & Witcoff, LTD Initiate Administrative proceedings and enjoining the unlawful sale and distribution by International Tan Markers, Inc. 2006/04/18   2008/03/14
FDA-2006-P-0088 Michael Patterson Stop LASIK Due to Informed Consent Problems 2006/05/19 2006/11/06 2007/07/20
FDA-2006-P-0347 Michael Patterson Enforce the single-use requirement for all Microkeratomes and their components used by Lasik 2006/05/19 2006/11/06 2007/07/20
FDA-2006-P-0287 Robert Habig, PhD, Clinical & Laboratory Standards Institute Amend practice of assessing the performance of medical device for determining in vitro susceptibility of bacteria or fungi to include CL SI 2006/06/26 2006/12/22 2007/03/05
FDA-2006-P-0074 American Association of Neurological Surgeons Cranial Orthoses exempt from Class II 2006/07/06 2007/01/02 2007/12/26
FDA-2006-P-0022 Bayer Corporation Removal of Labeling for Medisense Precision Advanced Diabetes Management System 2006/08/08   2006/09/06
FDA-2006-P-0336 Regeneration Technologies, Inc Bone Heterograft Reclassification 2006/08/17 2007/10/29 2007/10/25
FDA-2006-P-0021 Kerr Corporation Urge FDA to take Regulatory Action to Safeguard the Public from Violative Dental Device Distributed by Five Companies,
Including Devices Manufactured in Unregistered Facilities and/or Subject to Tampering		 2006/09/05   2007/01/08
FDA-2006-P-0143 Public Citizen Revoke FDA's Prior Approval of Vagus Nerve Stimulation(VNS) for management of Treatment-resistant Depression
(TRD) 		2006/09/06 2007/03/02 2020/05/25
FDA-2006-P-0141 John D. Stephens, M.D. Banning of Accu-Gender Blood Test 2006/09/11   2006/10/12
FDA-2006-P-0149 Washington Legal Foundation (WLF) Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew) 2006/10/02   2014/07/31
FDA-2006-P-0454 Jerry Staton Order the Church of Scientology to Clearly Disclose the Potential health hazards inherent in the use of the E-Meter and scientology's practice of "auditing." 2006/09/19 2007/03/16 2008/02/05
FDA-2006-P-0075 Michael Patterson Stop approving LASIK devices or Ban Lasik Devices 2006/12/18   2007/07/20
FDA-2006-P-0277 Michael Patterson Stop all approvals of medical devices used for implantable lens implants 2006/12/18   2007/07/20
FDA-2007-P-0116 Dean Andrew Kantis Take steps to insure the safety of Americans regarding the misuses of Lasik 2007/01/05    
FDA-2007-A-0279 AFrame Digital, Inc. AFram MobileCare Monitor system is not a medical device and should not fall under the regulatory authority of the FDA 2007/04/24    
FDA-2007-P-0005 Association of Medical Device Reprocessors FDA to Take Action to Subject Certain Cardiac Surgery Devices to 510(k) Requirements 2007/05/01 2007/10/29  
FDA-2007-P-0120 HiFi DNA Tech Petitioner request that FDA reclassify the human papillomavirus (HPV) DNA nested Polymerase chain reaction (PCR) detection device from class III to class II (513(f)) 2007/05/22    
FDA-2007-P-0288 Clinical & Laboratory Standards Institute (CLSI) Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility 2007/06/08 2007/12/06  
FDA-2007-P-0115 Clinical & Laboratory Standards Institute (CLSI) Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with penicillin 2007/06/29 2007/12/06  
FDA-2007-P-0117 Health Care Without Harm Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers 2007/08/14    
FDA-2007-A-0163 Alston & Bird LLP Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products 2007/08/24 2008/02/20 2008/06/02
FDA-2007-P-0118
FDA-2008-P-0066		 Thomas J. Quinn Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040.10(h); 21 CFR 820.170 2007/08/27   2009/09/08
FDA-2007-P-0464 Ralph D. Childs Electronic Product Radiation Control 2007/10/03   2009/09/08
FDA-2007-P-0184 Judy Slome Cohain Restore FDA approval to Tecsana Epi-no birth trainer and to remove the adverse event report on Tecsana Epi-No from FDA website 2007/12/12   2008/08/08
FDA-2007-P-0417 Consumer's Union Require that all print and electronic advertisements, including Internet advertisements, for implantable devices such as knee, hip, heart valves, cosmetic implants, and other devices 2007/12/17   2010/03/30
FDA-2008-P-0196 Carmel Pharma Withdraw Teva 510(k)s 2008/03/25 2008/08/20 2011/04/04
FDA-2008-P-0197 W.J. Kennick Tomatis Electronic Ear 2008/03/20 2008/09/12 2008/11/26
FDA-2008-P-0252 Richard W. Treharne, PhD Withdraw FDA Policy on Establishing Preamendments Status 2008/04/21   2010/12/21
FDA-2008-P-0282 Pneumex, Inc. Request that FDA reclassify Pneumex's device known as the Pneu-Vibe-Trac device from 510(k) requirements 2008/04/17   2008/06/18
FDA-2008-P-0159 Missouri State Board of Examiners for Hearing Instrument Specialists Application for Exemption from Preemption of Device Requirements 2008/03/05    
FDA-2008-N-0163/PRC Moms Against Mercury, et al. Reconsider the Classification of Dental Amalgam as Class II 2009/09/03   2015/01/27
FDA-2008-N-0163/PRC Citizens for Health, et al. Reconsider the Classification of Dental Amalgam as Class II 2009/09/03   2015/01/27
FDA-2008-P-0319 Lauranell H. Burch Ban the use of all Refractive Surgery Lasers for LASIK Surgery and Acknowledge and Enforce Remedy for the Misbranding of lasers used for LASIK 2008/05/28   2009/07/16
FDA-2008-P-0353 Fuerst, Humphrey, Ittleman, PL Petition for Stay of Action under 21 CFR 10.35 (concerning HairMax LaserComb medical devices) 2008/06/18   2008/10/03
FDA-2008-P-0388 Links Medical Products, Inc. Petition for Reclasssification Under 513(f) - Reclassify the Tablet Crusher and Pouch and collectively the Tablet Crushing System currently regulated under 21 CFR Part 880.6430, from Class I to Class II. 2008/07/09    
FDA-2008-P-0444 Codonics, Inc. FDA conduct an immediate inspection of the Datcard Systems, Inc. facilities, and that the PacsCube products, manufactured by DatCard Systems, Inc. be detained for a determination of seizure, injunction, and/or other appropriate relief 2008/08/06   2011/04/19
FDA-2008-P-0531 University of Virginia Health System Petition to Ban Cornstarch Powder on Medical Gloves 2008/10/02 2009/03/09 2018/04/04
FDA-2008-P-0533 Fuerst, Humphrey, Ittleman, PL Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices 2008/09/26    
FDA-2008-P-0585 Elliot Farber Artificial Eyes Lubricant 2008/11/04    
FDA-2008-P-0630 The Prescription Project Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices 2008/12/08 2009/05/31  
FDA-2008-A-0619 Jeffrey K. Shapiro Request for Section 9 Limitations on 510(k) Exemption Advisory Opinion 2009/12/01 2009/07/06 2011/03/15
FDA-2008-P-0638 Genetech, Inc. Require that all in vitro diagnostic tests intended for use in drug or biologic therapeutic decision making be held to the same scientific and regulatory standards 2008/12/09   2014/07/31
FDA-2009-P-0023 Electro Medical Systems Corp. Request that FDA (i) revoke 510(k) Number K072809 from FDA's Premarket Notification Database and (ii) recall the D-Actor Vibration Massage System from the U.S. Marketplace 2009/01/14    
FDA-2009-P-0094 American Association for Health Freedom Consider the Potential Risks of Exposure to Bisphenol-A for Dental Applications 2009/02/18 2009/08/10 2022/05/26
FDA-2009-P-0105 Williams Kherkher Hart Boundas, LLP Petition for FDA (1) inspection of all facilities where Medtronic sprint fidelis leads were manufactured and (2) the withdrawal of PMAs for the Medtronic sprint fidelis leads retroactive to September 2004 2009/02/18   2010/05/18
FDA-2009-P-0117 Kimberly-Clark Health Care Petition to ban Cornstarch Powder on Medical Gloves 2009/02/26   2017/10/16
FDA-2009-P-0150 Arthur K. Yellin Create a Separate Classification for Gloves used in Preparing and Administering Chemotherapeutic Drugs 2009/03/18   2010/08/24
FDA-2009-P-0207 Thomas Quinn Request for Immediate Class One Recall of Philips Medical Devices 2009/05/05 2009/11/27 2013/09/27
FDA-2009-P-0253 Scott A. Tolchin Petition for FDA to Inspect LASIK Cinics to Ensure Compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements 2009/05/25   2010/05/18
FDA-2009-P-0282 Pepper Hamilton, LLP Petition for FDA to Detain devices within the "Remote Medication Management Systems" device type 2009/06/19   2009/12/10
FDA-2009-P-0305 Hygeia II Medical Group, Inc. Petition Seeking Clarification and Review of Labeling for Breastpumps and Mother/Baby Products in Contact with Human Breastmilk 2009/07/01   2020/05/04
FDA-2009-P-0357 International Academy of Oral Medicine and Toxicology Petition to Ban Dental Amalgam or Classify the Device as Class III      
FDA-2014-P-023 Adaptive Engineering Inc. Exempt the Manually Operated Wheelchair Lift From the 510(K) Premarket Notification 2014/02/24    
FDA-2012-N-0378 BioElectronics Corporation Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses 2012/07/23    
FDA-2011-P-0641 Michael Carome, Public Citizen's Health Research Group Request to Ban Marketing of Non-Absorbable Surgical Mesh Products Designed and Labeled for Transvaginal Repair of Pelvic Organ Prolapse 2011/08/26    
FDA-2011-P-0374 Lanny J. Davis & Assoc., Robert R. Hopper & Assoc. Request Investigation of 3M Corporation and Its Conduct in BacLite Clinical Trial "A Covered Clinical Study" 2011/05/17    
FDA-2010-P-0580 Ralph McBride Clarify Approval of Medtronic Insulin Pump (P980022/S13) 2010/11/10 2011/04/14  
FDA-2020-P-2008 Philips Respironics

Requesting FDA to issue an exemption from the device tracking requirements under 21 C.F.R. Part 821 for the Care Orchestrator.

 2020/09/23 2020/12/18  
FDA-2020-P-2010 Philips Respironics Requesting FDA to issue an exemption from the device tracking requirements under 21 C.F.R. Part 821 for the Care Orchestrator Essence. 2020/09/23    
FDA-2020-P-1864 Kambiz Tajkarimi Requesting FDA to refrain from granting a 510(k) clearance or any other premarket clearance or approval to the Augmenta penile implant. 2020/09/11 2021/05/17  
FDA-2020-P-1831 Meenal Kheterpal Requesting the FDA to issue a determination on class labeling for all currently approved hedgehog inhibitors products. 2020/08/31    
FDA-2020-P-1181 Max D. Sterm
Todd & Weld LLP		 Request the FDA Stay Both of the two Effective Dates of FDA's Final Regulation Banning Electrical Stimulation Devices used to treat Self-injurious or Aggressive Behavior (the "Final Rule" or "Ban") Published in the Federal Register on March 6, 2020. 2020/03/23  

2020/09/10

2022/06/13
FDA-2020-P-1166 Eckert Seamans Cherin & Mellott, LLC
Michael P. Flammia		 Requesting the FDA to Immediately and Indefinitely Stay Both of the two Effective dates for its Final Regulation Banning Electrical Stimulation Devices ("ESDs") to Treat Self-injurious behavior ("SIB") or aggressive Behavior ("AB") 2020/03/23  

2020/03/27

2022/06/13
FDA-2020-P-1220 C Laser Inc.
Pattanam Srinivasan, M.D.		 Requesting the FDA 1) Overrule the Denial Order and Remove Srilas 7 from Automatic Class III to be placed in Class II (or I); 2) Recognize Srilas 7 as a "Non Significant Risk" Device for the Purpose of a Clinical Study and 3) Recognize Srilas 7 as a Breakthrough Device in Patient's Best Interest Consistent with FDA Own Written Communication Dated October 28, 2010 Granting the Device Expedited Review Status was Received on 03/20/2020. 2020/03/20   2021/07/17
FDA-2020-P-1003 John Coleman, M.A., M.S., PH.D. Requests that the FDA Initiate Rulemaking Procedures to Require Premarket Clearance for all Models of Fever Thermometers Sold OTC in the U.S. 2020/02/28 2020/06/08  
FDA-2020-P-0945 Dr. Ernest C. Chisena M.D., M.S., Orthopedic Attending Surgeon; Jahangir S. Rastegar, Ph.D., Associate Professor Mechanical Engineering Department Stony Brook Request the FDA to Force Exogen-Bioventus to Prove that Ultrasound is Responsible for Enhancing Fracture Healing as Claimed in their PMA 2020/02/25 2020/07/18  
FDA-2020-P-0893 Fisher Wallace Laboratories, Inc., Kelly Roman Requests that the FDA withdraw the Final Order regarding CES Devices (the "Final Order"), and to Convene a new Neurological Devices Panel of the Medical Devices Advisory Committee to review all Available Valid Scientific Evidence of Safety and Effectiveness Pertaining to CES Devices 2020/02/18 2020/07/23 2021/08/30
FDA-2020-P-0725 GBUK Group Ltd., Dr. Steve Curran Requesting the FDA to Remove the Requirement for the Medical Devices and Accessories Contained within Premarket Submission for K170371 to be Supplied with Adequate Directions for Use. 2020/02/11    
FDA-2020-P-0734 GBUK Group Ltd., Dr. Steve Curran Request the FDA to Remove the Requirement for Adequate Directions for use to be Supplied with the Medical Devices and Accessories listed in Premarket Submission for K170900. 2020/02/11 2020/07/18  
FDA-2020-P-0152 Hyman, Phelps & McNamara, P.C. on behalf of Coalition to Preserve Access to PGx Information In the Subject column insert the following: Petition regarding Pharmacogenetic (PGx) testing reports & allowing clinical labs to communicate gene-drug interactions, requests FDA to revise their Safety Communication & requests any other such policy communications to be done by rulemaking. 2020/01/09 2020/06/08  
FDA-2019-P-5048 Epstein Becker & Green, P.C. Requesting the FDA to refrain from asking a determination of certain subject devices' substantial equivalence to the IB-Stim (21 C.F.R. § 876.5340, product code QHH) without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. 2019/10/29 2020/04/27  
FDA-2019-P-3347 Sean Honard Requests that the FDA amendment to regulation 21 CFR §890.3690, Powered Wheeled Stretcher, to exempt the classification from premarket notification 2019/07/11   2019/12/31
FDA-2019-P-1800 Boditech Med Inc. Requests that FDA take all Administrative Actions Required for Reclassification from class III to class II of Medical Devices Associated with Product Code NCD (Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis) 2019/05/22    
FDA-2019-P-2038 American Dental Association Requesting FDA pursuant to FD&C Act §302(a) [21 U.S.C. §332(a)], an Injunction against SDC from Manufacturing or Continuing to Manufacture and from Continuing to Distribute and Sell in Interstate Commerce SDC's Plastic Teeth Aigner and Dental Impression Material Products. 2019/04/26   2019/05/30
FDA-2019-P-1800 Boditech Med Inc. Requests that FDA take all Administrative Actions Required for Reclassification from class III to class II of Medical Devices Associated with Product Code NCD (Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis) 2019/04/14   2019/04/16
FDA-2019-P-1009 Rossman Law Group, PLLC Requests the Commissioner to make a determination under 21 U.S.C. 1604(b)(3) regarding whether Lima Corporate S.P.A. was Required to Register with the Secretary under 21 U.S.C. 360 and/or list the Hip Implant Device at issue with the Secretary under 21 U.S.C. 360(j) 2019/03/04   2019/07/01
FDA-2018-P-4143 Aakash Agarwal Requesting the FDA Cease Clearing 510(k)s and approving PMAs for Reprocessing of Pedicle Screws and other Implantable Orthopedic Devices and Cease Clearing 510(k)s for Reusable Implantable Orthopedic Devices 2018/10/31 2017/04/02  
FDA-2018-P-3951 Chul-Hi Park, Ph.D. Requesting the FDA to Implement a Retroactive Regulatory Action to Remedy Deficiencies found in the 510(k) Process for the Surgical Stapler Devices 2018/10/18 2019/04/16 2021/10/12
FDA-2018-P-3896 Chul-Hi Park, Ph.D. Requesting the FDA to Prevent Certain Categories of New Devices from Being Cleared for Marketing without Sufficient Proof of Safety and Effectiveness for Staple Line Leaks 2018/10/13 2019/04/11 2021/10/12
FDA-2018-P-3843 Hoomad Noorchashm, MD, Ph.D. Requesting the FDA to Ban the use of Uncontained Laparoscopic Power Morcellators in Gynecological Operations 2018/10/10 2019/06/24 2020/12/30
FDA-2018-P-3806 Dr. Greg Grillo, DDS Requesting the FDA to Regulate Oral Moisturizer Products that are marketed for Mitigation, Treatment or Prevention of Dry Mouth and that Linger in the Mouth 2018/10/05  2019/04/02 2020/11/09
FDA-2018-P-3709 Jennifer Nelson Requesting the FDA to Reconsider the issue of Banning and Recall all Permanent Cautery Instruments (Spatula and Hook) for all Da Vinci Robotic Surgeries 2018/09/28 2019/03/04 2022/07/12
FDA-2018-P-3372 The Ohio State University
Lynne Gauthier, PhD		 Requesting the FDA to Expand FDA 510(k) Exemption Status to all Small and Portable Sensors that can be used for Relaxation of Muscular Reeducation 2018/09/05   2021/04/21
FDA-2018-P-3102 Richard M. Fleming, MD, JD Request that the FDA respond to the applicable pharmaceutical companies, mammography and nuclear camera producers to address profiting from the misinformation regarding redistribution of the Technetium-99m Isotopes Sestamibi and Tetrofosmin, address misinformation being promulgated by the nuclear camera companies reporting that their SPECT and PET cameras are "quantifying" disease. 2018/08/08   2019/07/09
FDA-2018-P-2073 LMS Direct Research Foundation Requesting the FDA seriously revisit and reconsider the issue of banning all laproscopic and hysteroscopic power morcellators for all GYN surgeries. 2018/05/30 2018/06/12 2020/12/30
FDA-2018-P-1469 Epstein Becker & Green, P.C. Requesting FDA from making a determination of certain subject devices' substantial equivalence to the NSS-2 BRIDGE (21 C.F.R. § 882.5896) without preclinical studies and at least one clinical trial. 2018/04/10 2018/10/18  
FDA-2018-P-0599 National Pediculosis Association, Inc. Requesting FDA to update the Website and other Educational Collateral for the LiceMeister Comb for the Management and Treatment of Head Lice 2018/02/07 2018/09/26 2020/01/17
FDA-2017-P-6663 Dr. S. Albert Edwards Requests that FDA Investigate Edwards Lifesciences' Marketing, in Interstate Commerce the Myxo ET Logix 5100, Annuloplasty Ring 5110, during 2007 to 2009 without approved 510k or PMA 2017/11/27 2018/04/26 2020/05/25
FDA-2017-P-5124 Hyman, Phelps & McNamara, PC Requesting FDA to Exempt OTC Denture Repair Kits a Class II Device from Premarket Notification Requirements of section 510(k) of the FDC Act. 2017/08/22   2018/01/31
FDA-2017-P-4939 Chul-Hi Park, Ph.D Requesting FDA to take Administrative Action to Prevent Certain Categories of New Devices from being cleared for marketing without sufficient proof of Safety and Effectiveness 2017/08/14 2018/05/21 2021/10/12
FDA-2017-P-4335 William Bonificio Request to Amend the Classification of Glutaraldehyde-based tooth desensitizers from devices to drugs, or revoke their current classification as devices 2017/07/18 2018/04/16 2021/05/26
FDA-2017-P-3884 Riverain Technologies, LLC. 513(e) Petition for Reclassification for Riverain Technologies Clear Read - Detect CADe Device from Class III (PMA Approval P000041) to Class II 2017/06/14   2018/06/04
FDA-2017-P-3405 Michael Boggi Requesting the FDA to initiate rulemaking requiring home medical device manufacturers to protect against the mixing of two different individuals' data on a smart phone app or other similar software. 2017/05/30 2017/11/02 2018/07/24
FDA-2017-P-3330 Anonymous Requesting FDA to reconsider or revoke 510K Pre-Market Notification K151763 2017/05/23 2017/11/17 2020/01/28
FDA-2017-P-3413 Salter Labs Reclassification for the EtC02 Tracheal Tube Adaptor (airway adaptor) Device from Class II to Class I (510(k) exempt) 2017/05/23    
FDA-2017-P-2561 STL International, Inc.
Neal Hartman, Regulatory Consultant		 § 513(e) Petition for Reclassification of Hang Ups InvertAlign 2017/04/24   2018/06/18
FDA-2017-P-2233 Mercury Free Dentistry Requesting the FDA to amend its mercury amalgam rule 74 FR 38686 to implement measures to end amalgam use in children under age 15, pregnant women and breastfeeding mothers. 2017/04/07 2017/10/26 2022/05/26
FDA-2017-P-1226 INRange Systems, Inc. Petition requesting FDA take action to protect patient safety by detaining the product manufactured or sold by PharmRight Corporation under the product name "Livi" 2017/02/27   2017/09/25
FDA-2017-P-1002 INRange Systems, Inc. Petition requests FDA detain the device marketed as "LUMMA." 2017/02/15   2017/09/22
FDA-2017-P-0290 Malaysian Rubber Export Promotion Council (Embassy) Request the FDA to extend the effective date of a Final Rule (FDA-2015-N-5107) from January 18, 2017 to March 18, 2017 to allow shipments carrying lightly powdered gloves to make appropriate arrangements at the port of entry to either ship elsewhere or re-label and re-pack for distribution to non-medical markets in the United States. 2017/01/17   2017/06/26
FDA-2016-P-4587 Mallinckrodt Pharmaceuticals Requesting the FDA (CDER and CDRH) to review the inhaled nitric oxide drug products and nitric oxide delivery systems 2016/12/28   2017/05/26
FDA-2016-P-4094 Adapt Pharma Operations Ltd Requesting FDA (CDER and CDRH) to require proposed generic versions of Intranasal to provide specific data to support interchangeability. 2016/11/29   2017/04/21
FDA-2016-P-3674 Consumers for Dental Choice
Charles G. Brown		 Requesting the FDA to warn against amalgam use in children, pregnant women, and other sensitive populations 2016/11/02 2017/04/27 2022/05/26
FDA-2016-P-3195 Wood, Herron & Evens, L.L.P. Requesting the FDA to detain the devices marketed as MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm. 2016/10/06 2016/10/07 2017/03/08
FDA-2016-P-2559 Jonathan W. Emord, et. al. Emord and Associates, P.C. Requests that the FDA either promulgate a final regulation making electroconvulsive therapy (ECT) devices banned devices or maintain the Class III classification of the devices and issue a final order establishing the effective date for premarketapproval (PMA) for all ECT devices 2016/08/25 2017/02/02 2018/12/21
FDA-2016-P-2497 Clinical Decision Support Coalition Requested FDA to issue a guidance document 2016/08/18 2017/02/02  
FDA-2016-P-2072 Pacific-Link Consulting Requesting FDA guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in all settings (Including Non-Medical Settings) by Individuals 2016/07/13   2016/12/08
FDA-2016-P-1955 Mallinckrodt Pharmaceuticals Requesting the FDA to formally designate INOMAX and the company's 510(k) cleared specialized delivery system, the INOmax DSIR Plus, as a drug-device combination product pursuant to 21 C.F.R. § 3.2(e) 2016/06/30   2016/11/23
FDA-2016-P-1398 Hooman Noorchashm, MD, PhD Requesting that the FDA revoke FDA clearance of the Pneumoliner Containment System for use with Power Morcellators 2016/05/31 2016/11/17 2020/12/30
FDA-2016-P-1303 Charles G. Brown
Mercury Free Dentistry		 Requesting FDA to require patient labeling for dental amalgams 2016/05/19 2016/11/17 2022/05/26
FDA-2016-P-1115 Mostyn Law Firm Request the FDA to issue an immediate Class I recall of all BSC products made with counterfeit, Chinese resin. 2016/04/06 2016/09/21  
FDA-2016-P-1026 Germaine Laboratories, Inc. Requests FDA to exempt devices classified as "Method, Metallic Reduction, Glucose (Urinary, Non Quantitative)" in 21 CFR 862.1340, from the premarket notification requirement (510(k)) 2016/03/21   2016/09/06
FDA-2016-P-0159 Biorex Labs LLC Requests FDA to exempt devices classified as "Method, Metallic Reduction, Glucose (Urinary, Non Quantitative)" in 21 CFR 862 .1340, from the premarket notification requirement (510 (k)) 2016/01/07   2016/07/01
FDA-2015-P-4945 Ryszard Rokicki Request FDA to order Bayer to use petitioners patented methodology on Essure 2015/12/21 2016/03/14 2018/05/09
FDA-2015-P-3876 World Alliance for Mercury-Free Dentistry Requests FDA to make the changes included in this Citizen Petition to FDA's mercury amalgam rule so that the rule will conform with the Minamata Convention on Mercury 2015/10/20 2016/04/19 2022/05/26
FDA-2015-P-3778 Orthofix, Inc. Requests FDA to enact the proposed rule dated 4/19/2013 to facilitate implementation of the Universal Device Identification Regulation 2015/10/16 2016/04/11 2016/08/02
FDA-2015-P-3365 Inrange Systems, Inc. Requests FDA to detain Life Integrating Technologies product Lumma 2015/09/18 2015/12/16 2015/12/16
FDA-2015-M-1065 Reed Smith LLP Reconsideration of PMA Approval of AutoSPray Dural Sealant 2015/09/14 2015/10/16 2019/12/18
FDA-2015-P-3364 Leroy L. Hamilton, Ph.D. Request FDA to Complete and return "return receipt" postcards when they receive Certified or Registered letters with the green return receipt postcards attached 2015/09/08 2016/06/21 2018/04/16
FDA-2015-P-3107 DuVal & Associates on behalf of Ferrosan Medical Devices A/S Requests FDA refrain from taking further action to reclassify collagen-based absorbable hemostatic devices 2015/08/25 2016/01/21  
FDA-2015-P-3108 DuVal & Associates on behalf of Ferrosan Medical Devices A/S Requests FDA refrain from taking further action to reclassify collagen-based absorbable hemostatic devices 2015/08/25   2021/09/29
FDA-2015-P-2854 Olsson Frank Weeda Terman Matz on behalf of Provensis Ltd. Requests FDA withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System 2015/08/05    
FDA-2015-P-2820 Alston and Bird (the Center for Responsible Science) Requests FDA modify existing regulations that govern requirements for INDs, IDEs, and NDAs 2015/08/03 2016/03/11  
FDA-2015-P-2481 SweetSpot Diabetes Care, Inc. requesting reclassification of diabetes data management software devices from class II to class I 2015/07/15   2019/11/07
FDA-2015-P-2375 Public Citizen Health Research Group Requests that FDA withdraw approval of Seprafilm Bioresorbable Membrane, premarket approval application number P950034, and initiate a mandatory recall of this product 2015/07/07 2015/10/02 2021/01/29
FDA-2015-P-1924 Hunton and Williams LLP Requesting FDA issue an order declaring Zeltiq CoolSculpting System to be NSE 2015/05/29 2015/10/08 2016/03/14
FDA-2015-P-1674 Kelly Quick, Globus Medical, Inc FDA not enforce 801.30(a)(1) for implants that were commercially distributed and held for sale to potential purchasers prior to the regulation implementation deadline identified by the FDA by device class 2015/05/12   2020/02/26
FDA-2015-P-1197 Brian Orwat, Stryker Medical Request amendment to Regulation 21 CFR 890.3110 Electric Positioning Chair to Exempt Classification from Premarket Notification 2015/04/13   2015/10/09
FDA-2015-P-0703 Sarah Salem-Robinson Issue Ban on Laparascopic Power Morcellators 2015/03/05   2020/12/30
FDA-2015-P-0569 Marcus J. Susen & Justin Parafinczuk, Koch Parafinczuk & Wolf, P.A. Request that FDA take various actions against Bayer Healthcare Pharmaceuticals, Inc., and its subsidiaries regarding the "Essure" product 2015/01/24   2015/03/26
FDA-2015-P-0095 Mark DuVal, DuVal and Assoc. (Leonhard Lang, GmbH) Request that the FDA grant an exemption from the medical device tracking requirements recently ordered 2015/01/09    
FDA-2015-P-0051 Christopher E. Bossi, Inrange Systems, Inc. Take action to protect patient safety by detaining the product manufactured or sold by; PharmRight Corporation under the product name "Livi" 2015/01/06   2015/03/02
FDA-2015-P-0014 Edward L. Boshnick, O.D.; Roger D. Davis, Ph.D.; Richard B. Smith, Ph.D. Request that the FDA add a black box warning concerning the high incidence of induced visual symptoms to the device labeling of all excimer lasers used in laser eye surgery presently on the market in the U.S. 2015/01/05 2015/06/18 2022/09/05
FDA-2014-P-0724 Barbara Spohn-Lillo, Rocky Mountain Anaplastology Inc. FDA to Consider Barbara Spohn-Lillo as a Clinical Practitioner and Exempt Rocky Mountain Anaplastology, Inc. from Device Registration and Listing 2014/11/03 2015/04/30 2016/08/30
FDA-2014-P-0687 Margaret Moline Requesting FDA to revoke import alerts EPFX device 2014/10/31 2014/04/22 2016/08/17
FDA-2014-P-1673 Tia Gonnella Request that the Commissioner of Food and Drugs amend the current content and format of High Level Disinfectant characterization for use with semi critical items employed in the healthcare setting 2014/10/23 2014/12/22  
FDA-2014-V-1503 Timothy J. Connors, Integra LifeSciences Corporation Approve a variance request that considers the device as a compliant system consisting of the electrode connected to the Integra EEG cable (as opposed to considering only the electrode) 2014/10/02 2015/03/30  2015/05/22
FDA-2011-P-0022/PRC Waxler Regulatory Consultancy LLC Request that FDA Withdraw Premarket Approvals for all LASIK Excimer Laser Devices & Issue a Voluntary Recall of These Devices - Reconsideration Petition 2014/09/02 2015/01/23 2016/10/26
FDA-2014-P-0919 Shumaier FDA withdraw its draft guidance regarding Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products and refrain from taking further action that directly or indirectly restricts availability of hearing assistive devices and personal sound amplification products 2014/07/01 2014/12/23 2021/10/23
FDA-2014-P-0831 OrthoFix FDA not enforce 801.30(a)(1) for instruments in the control of third parties, provided labeling activities took place prior to the regulation implementation deadline identified by the FDA by device class 2014/06/20 2014/12/17 2019/07/16
FDA-2014-P-0825 OrthoFix Requesting that the FDA not enforce 801.30(a)(1) for implants in the control of third parties provided labeling activities took place prior to the regulation implementation deadline identified by the FDA device class. Also requests that FDA refrain from requiring relabeling for product labeled prior to regulation implementation deadline and its 3 year implementation period 2014/06/19 2014/12/17 2019/07/16
FDA-2014-P-0802 Moon T. Kwon FDA withdraw its draft guidance and refrain from taking any action affecting personal sound amplification products and cease further efforts to expand the scope of the generic device known as a hearing aid 2014/06/17 2014/07/22 2021/10/23
FDA-2014-P-0654 Edwards Life-Sciences FDA grant a variance from specific quality system requirements for the delivery systems and accessories of the SAPIEN XT THV 2014/05/20    
FDA-2014-P-0445 Robert Larry Lytle Requests that FDA recognize that the private member associations created by Petitioner deal only with PMA members (not with the public), that the lawful acts of the PMAs are generally immune from or beyond the scope and purview of FDA's laws and regulations. 2014/04/14 2014/05/30 2016/11/15
FDA-2014-P-0427 Medicem Technology Reclassify Dilapan 2014/04/10   2014/08/14
FDA-2013-P-0949 Garrett Skelly, Esq. Reconsideration - Amend External Prosthetic Order and Procedures and Classification of All External Prosthetic Devices in 21 CFR 890.3420 and 21 CFR 890.3500 to Read as Both "Prescription" and "OTC" in Particular C-Leg K991590 2014/04/08   2020/05/30
FDA-2014-P-0290 Leroy L. Hamilton Direct CDRH to Include Product Codes Where Appropriate in Notices & Other Information Published for Specific Categories of Medical Devices 2014/03/10   2014/05/16
FDA-2014-P-0283 Leroy L. Hamilton Revise Form FDA 3429 to Indicate the Appropriate Classification of a Medical Device 2014/03/06   2014/05/16
FDA-2022-P-3013 Hooman Noorchashm MD, PhD Refer Becton Dickinson and Company's deliberate concealment of a bacterial ingress and contamination breach defect, in that company's 510(k) cleared GENESIS line of Rigid Sterilization Containers, to the Department of Justice for violation of the False Claims Act 2022/11/28    
FDA-2022-P-3053 Ombu Enterprises, LLC FDA make the UDI information a publicly available field in the MAUDE database and the Recall database 2022/11/30    
FDA-2022-P-3201 Derry Anderson Requesting that the FDA issue via regulation, changes to 21 CFR 868.5470, with proposed language providing that “hyperbaric chambers shall comply with the FDA’s recognized consensus standards for hyperbaric chambers, i.e. NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) and update the FDA’s recognized consensus standards for hyperbaric chambers, product code “CBF” (21 CFR 868.5470), to the most recent editions of NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) 2022/12/13    
FDA-2022-P-2644 Leigh Spotten FDA take all administrative actions required for reclassification for the medical devices associated with Product Code OAY; FDA regulatory classification details of which as on May 17, 2019 2022/10/25    
FDA-2022-P-0234 Katherine Price Snedaker, LCSW
PINK Concussions		 Requesting FDA rescind SyncThink, Inc.’s 510(k) clearance K202927 for EYE-SYNC Indications for Use (IFU) as an aid in the diagnosis of a concussion 2022/02/27 2022/07/08 2022/11/06
FDA-2023-P-0203 Najam Azmat  Requests that the FDA immediately, on a fast-track mandate that a barrier attachment separating the wheel of the wheelchair from the propulsion rim be placed on all wheelchairs, existing as well as those being newly manufactured to prevent soiling of hands from ground contamination while propelling the wheelchair 2023/01/19    
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